STERILE DOPAMINE CONCENTRATE BP

Posology Adults Where appropriate, the circulating blood volume must be restored with a suitable plasma expander or whole blood, prior to administration of dopamine hydrochloride. 5mcg/kg/min in patients who are likely to respond to modest increments of heart force and renal perfusion.

In more severe cases, administration may be initiated at a rate of 5mcg/kg/min and increased gradually in 5 to 10 mcg/kg/min increments up to 20 to 50 mcg/kg/min as needed. If doses in excess of 50 microgram/kg/min are required, it is advisable to check urine output frequently.

Should urinary flow begin to decrease in the absence of hypotension, reduction of dopamine dosage should be considered. It has been found that more than 50% of patients have been satisfactorily maintained on doses less than 20 mcg/kg/min.

In patients who do not respond to these doses, additional increments of dopamine may be given in an effort to achieve adequate blood pressure, urine flow and perfusion generally. Treatment of all patients requires constant evaluation of therapy in terms of blood volume, augmentation of cardiac contractility, and distribution of peripheral perfusion and urinary output.

Dosage of dopamine should be adjusted according to the patient's response, with particular attention to diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias as indications for decreasing or temporarily suspending the dosage.

Patients who have been treated with MAO inhibitors 2-3 weeks prior to administration of dopamine requires a substantially reduced dosage. (The starting dose should be reduced to at least 1/10 of the usual dose. Paediatric population The safety and efficacy of dopamine in paediatric patients has not been established.

Elderly In clinical trials with parenteral Dopamine, the number of patients aged 65 years or older included was not sufficient to determine if they behave differently from younger patients. Generally, dose selection in elderly patients should be cautious and an initial lower dose is regularly used.

Close monitoring is suggested for blood pressure, urine flow and peripheral tissue perfusion. Method of administration To be administered by intravenous infusion only after dilution with the appropriate diluents. Dopamine hydrochloride should be infused into a large vein whenever possible, preferably with an infusion syringe pump system.

Adverse reactions to dopamine are related to its pharmacological action. The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

More common reactions include Cardiovascular:

Ectopic heart beats, tachycardia, anginal pain, palpitation, hypotension and vasoconstriction.

Gastrointestinal:

Nausea and vomiting.

Nervous System:

Headache, anxiety, tremor.

Respiratory:

Dyspnea. Renal and urinary Polyuria. disorders: Investigations: Serum glucose level increased, BUN level increased.

Less common reactions include Biochemical Azotemia Abnormalities:

Cardiovascular: Aberrant conduction, bradycardia, widened QRS complex, hypertension, gangrene, fatal ventricular arrhythmias have been reported on rare occasions.

Eye Disorders:

Mydriasis.

Nervous System:

Piloerection.

Serious or Life-threatening Reactions:

Gangrene of the extremities has occurred following higher doses and in lower doses patients with pre-existing vascular disease. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Dopamine should not be used in patients with hyperthyroidism. Cyclopropane and halogenated hydrocarbon anaesthetics should be avoided. Dopamine should be used with caution in patients with narrow angle glaucoma. Dopamine should be used with caution in patients with benign prostatic hyperplasia with urinary retention.

Patients who have been treated with MAO inhibitors prior to dopamine should be given reduced doses; the starting dose should be one tenth (1/10) of the usual dose. Excess administration of potassium-free solutions may result in significant hypokalaemia.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary oedema. Dopamine hydrochloride should not be added to sodium bicarbonate or other alkaline solution as drug inactivation will occur.

Conditions like hypoxia, hypercapnia and acidosis can reduce dopamine efficacy and/or increase the incidence of adverse events and should therefore identified and corrected before or during administration of Dopamine hydrochloride.

Regular clinical and biochemical assessment is necessary to monitor changes in fluid, electrolyte or acid-base status during prolonged treatment and whenever the patient condition demands it. During treatment with Dopamine hydrochloride, blood pressure, heart rate, urine output, EKG and cardiac output should be monitored.

If tachyarrhythmias or increase in ectopic beats are observed, Dopamine hydrochloride should be reduced, if possible. Hypovolaemia should be corrected where necessary prior to dopamine infusion. Low doses should be used in shock due to acute myocardial infarction.

e. a marked decrease in pulse pressure) is observed, the infusion rate should be decreased and the patients observed carefully for further evidence of predominant vasoconstriction activity, unless such an effect is desired. Patients with a history of peripheral vascular disease should be closely monitored for any changes in colour or temperature of the skin of the extremities.

1. Dopamine should not be used in patients with phaeochromocytoma. Dopamine should not be used in the presence of uncorrected atrial or ventricular tachyarrhythmias or ventricular fibrillation.